Blue Ortho
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 9
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0209-2025 | Class II | Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide pred | August 30, 2024 |
| Z-0288-2021 | Class II | Instructions For Use document of the GPS Trackers. | September 10, 2020 |
| Z-1149-2020 | Class II | Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic sur | September 22, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K233299 | ExactechGPS® System | January 26, 2024 |
| K232521 | ExactechGPS® Total Ankle Application | November 16, 2023 |
| K213877 | ExactechGPS® System | May 2, 2022 |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | January 6, 2022 |
| K193618 | ExactechGPS System | September 2, 2020 |
| K173372 | ExactechGPS Total Shoulder Application | November 24, 2017 |
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | April 5, 2017 |
| K152764 | EXACTECH GPS | July 13, 2016 |
| K100742 | EXACTECH GPS | October 21, 2010 |